(88 days)
Not Found
No
The summary describes a passive electrode device for signal acquisition, with no mention of AI/ML processing or analysis of the acquired signals.
No
The device is described as being used for recording and monitoring physiological signals (EMG, EEG, Evoked Potentials), which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
The device is intended for recording and monitoring physiological signals (EMG, EEG, Evoked Potentials) for diagnostic purposes, rather than therapeutic intervention. Monitoring these signals directly aids in diagnosis.
No
The device description explicitly states it is a "cutaneous electrode" and mentions reusable and disposable versions, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "non-invasive use with recording and monitoring equipment... of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials." These are physiological signals measured directly from the body, not from samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces that the electrodes are applied "directly to a patient's skin to record physiological signals."
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to acquire electrical signals directly from the body's surface.
N/A
Intended Use / Indications for Use
The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Product codes
GXY
Device Description
A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP) and the electroencephalographic/evoked potentials reading is a completely non-invasive procedure that can be applied repeatedly to patients, normal adults, and children with virtually no risk or limitation. The electrodes are delivered non sterile and are available in reusable and disposable versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
normal adults, and children
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Technomed Europe has been bench testing the Cup Electrode to confirm performance characteristics of this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
| Attachment C: | 510(k) Summary | K072016 |
|---|---|---|
| Manufacturer: | Technomed Europe | |
| Amerikalaan 71 | ||
| 6199 AE Maastricht Airport | ||
| The Netherlands | OCT 19 2007 | |
| Submitted by: | Technomed Europe | |
| Amerikalaan 71 | ||
| 6199 AE Maastricht Airport | ||
| The Netherlands | ||
| Tel.: (+31) 43-408 6868 | ||
| Fax: (+31) 43-408 6888 | ||
| Contact person: | Mr. Maurice Roost | |
| Manager Research & Development | ||
| E-mail: mroost@technomed.nl | ||
| Date: | 07 September, 2007 | |
| Proprietary Name: | Cutaneous Electrodes | |
| Common/usual Name: | Cup Electrodes | |
| Classification Name: | Cutaneous Electrode is classified as class II per | |
| 21 CFR section 882.1320. Product code GXY. | ||
| Substantial Equivalence: | K061148: Rhythmlink Disc Electrodes | |
| Device description: | A cutaneous electrode is an electrode that is applied directly to | |
| a patient's skin to record physiological signals. In other words | ||
| cutaneous devices are used in the acquisition of signals for the | ||
| purpose of monitoring and recording Electroencephalograph | ||
| (EEG), Electroencephalography (EEG), and Evoked | ||
| Potentials (EP) and the electroencephalographic/evoked | ||
| potentials reading is a completely non-invasive procedure that | ||
| can be applied repeatedly to patients, normal adults, and | ||
| children with virtually no risk or limitation. The electrodes are | ||
| delivered non sterile and are available in reusable and | ||
| disposable versions. | ||
| Reusable: | Reusable Cup Electrodes have a disc manufactured with a | |
| variety of materials which include: silver, Ag/AgCl, Gold | ||
| Plated. The disc is permanently adhered to a lead wire. The | ||
| insulated lead wires terminate using a molded touch proof | ||
| connector (DIN 42-802) for electrical safety. The cup | ||
| electrode may be sterilized using steam autoclave. The cup | ||
| electrodes are available in an adult version and a pediatric | ||
| version. | ||
| Disposable: | These electrode are for single patient use only. Disposable | |
| Cup Electrodes have a disc manufactured of molded ABS, | ||
| Ag/AgCl Plated. The disc is permanently adhered to a lead | ||
| wire. The insulated lead wires terminate using a molded touch | ||
| proof connector (DIN 42-802) for electrical safety. |
1
| Intended Use: | The Cup Electrodes are intended for non-invasive use with
recording and monitoring equipment, (active and reference),
of Electromyography (EMG), Electroencephalograph (EEG)
and Evoked Potentials (EP). |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to predicates: | The design, materials, chemical composition, packaging and
other technological characteristics of the subject device is
equivalent to those of the predicate devices. |
| Non-clinical data: | Technomed Europe has been bench testing the Cup Electrode
to confirm performance characteristics of this device. |
| Conclusion: | The comparison to the predicate devices demonstrate that the
cup electrodes are safe and effective and are substantially
equivalent to the predicate devices. |
:
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image.
OCT 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Technomed Europe c/o Mr. Maurice Roost, Manager Research & Development Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
Re: K072016
Trade/Device Name: Cup Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode. Regulatory Class: Class II Product Code: GXY Dated: July 20, 2007 Received: July 23, 2007
Dear Mr. Roost:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melkerson
Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and -Radiological Health-
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Cup Electrodes
Indications For Use:
The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K012014 |
|---|---|
| --------------- | --------- |
| Page 1 of | 1 |
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